Conduct↦Monitoring↦Routine Monitoring Visit↦Follow-Up Letter
What is it? Why is it important?
The monitor forwards a Follow-Up (FU) letter to the Site-INV summarizing:
- The scope of the performed RMV, including a list of the performed action items
- Current and ongoing unresolved issues with suggestion for improvement and a timeline for resolution
The FU letter can also be an e-mail that includes all necessary information.
What do I need to do?
If you are the study monitor, write a short FU to the Site-INV and include:
- The status and progress of participant recruitment
- Monitoring activities performed (e.g. ICs reviewed, SD verification performed)
- If applicable, study protocol and/or GCP deviations
- Delivered supplies (e.g. lab kits, IMP/MD)
- Current and ongoing unresolved issues with relevant improvement and control measures and a timeline for resolution
The FU letter should
- Not contain any surprises or issues that were not previously discussed with the site
- Describe the status and progress of the study during the monitoring visit
The Site-INV files the FU letter in the ISF. The monitor retains a copy of the letter
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
References
ICH GCP E6(R2) – see in particular guidelines
- 4.5 Protocol compliance
- 5.18 Monitoring activities
- 6.10 Access to source data / documents
ISO 14155 Medical Device – see in particular section (access liable to costs)
- 9.2.4.7 Monitoring reports